Newsflash | Europe | Final version of guidance on poison centres notifications- CLP
Final version of guidance on poison centres notifications- CLP
From 5th March 2019 the Guidance on harmonised information relating to emergency health response – Annex VIII to CLP is available in ECHA’s website.
The aim of this guidance is to provide information and a support tool to companies responsible of hazardous mixtures when they have to notify them to European Poison Centres. Manufacturers are not the only responsible with the obligation to do this submission. Importers and downstream users placing hazardous mixtures on the market are also responsible for submitting the required information to European Poison Centre of the corresponding Member State.
The obligations for industry to submit information on hazardous mixtures comes from Article 45 and Annex VIII to the CLP Regulation.
On 23rd March 2017, the European Commission published COMMISSION REGULATION (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response.
This amendment adds Annex VIII to CLP - Harmonised information relating to emergency health response and preventative measures describing the requirements and information necessary to submit hazardous mixtures. Depending on the type of users of substances and mixtures, the applicable date is different:
- For consumer use, it will apply from 1 January 2020
- For professional use, it will apply from 1 January 2021
- For industrial use, it will apply from 1 January 2024
For this reason the European Chemicals Agency (ECHA) has developed IT tools for preparing the information to be submitted in PCN portal (currently under development). The first version of the portal for submitting poison centre notifications will be available from 24 April 2019.
The IT tools and the access to PCN portal shall be through the Poison centre’s website.
PCN format
The submission of hazardous mixtures shall be done in an XML format with information according to Annex VIII to the CLP regulation. The main information is:
- Identification of the mixture and of the submitter
- Classification of the mixture, label element and toxicology
- Additional information (colour, pH, physical state, packaging, intended use (EuPCS) and uses)
- Product identifiers of the mixture components (Chemical/trade name of the components, CAS number (if applicable), EC number (if applicable), UFI (if applicable), Concentration, Classification of mixture components (substances and MIM)(if applicable))
The aim of this format is to harmonise the information made available to poison centres in cases of poisoning incidents in the EU.
The submission shall be in the official language of the Member State where the mixture is placed on the market.
Click here for more information and download the PCN formats and their guides from Poison centre’s website.
European Product Categorisation System (EuPCS)
The intended use of the mixture shall be described in accordance with a harmonised product categorisation system (EuPCS) provided by the Agency. More information about this classification and a practical guide can be found at Posion centre’s website.
Unique Formula Identifier (UFI)
UFI is a unique 16-digit alphanumeric code (example: UFI: E600-30P1-S00Y-5079) that unambiguously links the submitted information on the composition of a hazardous mixture to the corresponding poison centre.
This UFI code shall be created by submitter by electronic means made available by the Agency in Poison centre ‘s website.
The submitter shall print or affix the UFI on the label of a hazardous mixture. The UFI shall be preceded by the acronym “UFI” in capital letters and it shall be clearly visible, legible and indelibly marked.
